Quality Investigator - Westborough, United States - Pyramid Consulting, Inc

Description

Immediate need for a talented Quality Investigator. This is a 06+ Months Contract opportunity with long-term potential and is located in Westborough, MA (Onsite). Please review the job description below and contact me ASAP if you are interested.

Job ID:

Pay Range: $65/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).

Key Responsibilities:

• Execute the triage, investigation, and closure of product quality complaints.
• Run trend reports and perform statistical analysis of trends to identify emerging issues across various product groups and provides analysis around failure mode signals.
• Support in CHU complaint handling and QA product root cause investigations as deemed appropriate by management. Support with tracking major issues and related corrective actions.
• Works with R&D, Manufacturing Engineers, Product Managers and Supplier Quality to ensure robust triage of product complaints and associated investigations; responsible for documentation of objective evidence in QMS records.
• Writes and reviews technical reports and investigation/CAPA memos which are communicated to customers.

Key Requirements and Technology Experience:

• Bachelor's degree required; additional training/education preferred through ASQ (or relevant society) and/or Master's level program.
• Minimum 7 years relevant experience industry experience (e.g. GMP medical device, pharmaceutical) required.
• Minimum 7 years relevant experience dealing with post market surveillance activities (complaint triage, investigations, CAPA, etc.).
• Experience with cGMP and/or ISO 13485 including documentation, audit, and post market surveillance.
• Demonstrated understanding and application of 21CFR Regulations with respect to Customer Complaints.

Our client is a leading Healthcare Industry and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.

Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.